Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients

Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00295607

Acronym

CHASE

Enrollment

138

Registered

2006-02-24

Start date

2005-06-30

Completion date

2008-06-30

Last updated

2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Liver Transplantation

Keywords

Tacrolimus, Liver Transplantation, Immunosuppression, Adult, Treatment Outcome

Brief summary

This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.

Detailed description

A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.

Interventions

DRUGTacrolimus

immunosuppression

DRUGsteroids, monoclonal anti-IL2R antibody

immunosuppression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study. * Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.

Exclusion criteria

* Recipient of multi-organ transplant * Recipient of an auxiliary graft * Patient is receiving ABO incompatible graft * Patients requiring immunosuppressive treatment * Patients requiring ongoing corticosteroid therapy. * Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. * Patient or donor is known to be HIV positive. * Patient is allergic or intolerant to study medication * Patient is pregnant or breast-feeding. * Patient has been previously enrolled in this study

Design outcomes

Primary

Measure	Time frame
Viral load of HCV at 12 months post transplantation	12 months

Secondary

Measure	Time frame
Biopsy-proven acute rejection	12 months
Acute rejection	12 months
Patient and graft survival	12 months
Incidence of adverse events	12 months

Countries

Czechia, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026